Akorn Recalls Sulfamethoxazole and Trimethoprim Oral Suspension for Dissolution Failures
Akorn Inc is recalling 55,968 bottles of Sulfamethoxazole and Trimethoprim Oral Suspension because the product failed to meet dissolution specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which is reasonably likely to cause temporary or medically reversible health consequences. The hazard is a failure to meet dissolution specifications, which is a quality control issue rather than a contamination or mislabeling of a common allergen.
Plain-English summary
Akorn Inc is voluntarily recalling 55,968 bottles of Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL, Grape Flavor, 16 fl oz. (473 mL). The product is distributed nationwide and is manufactured by HI-TECH PHARMACAL CO., INIC, located in Amityville, NY. The recall involves specific lots with expiration dates ranging from January 2018 to March 2018.
The recall was initiated because the product failed to meet dissolution specifications. Dissolution is a critical quality attribute that ensures the medication releases its active ingredients at the appropriate rate in the body. When this specification is not met, the medication may not work as intended.
Consumers and healthcare providers should check their inventory for the affected NDC 50383-824-16 and the specific lot numbers listed in the recall notice. If the product is found, it should be discontinued and returned to the distributor or pharmacy for proper disposal or credit. Patients currently taking this medication should consult their healthcare provider for alternative treatment options.
The recalled product
- Product
- Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape Flavor, Rx Only, 16 fl oz. (473 mL), HI-TECH PHARMACAL CO., INIC, Amityville, NY 11701, NDC 50383-824-16
- Manufacturer
- Akorn Inc
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 55,968
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Lot# 348913
- Exp.01/18
- Lot# 349552
- Exp.03/18
- Lot# 349681
- Exp. 03/18
- Lot# 349683
- Lot# 349685
- Lot# 349687
- Lot# 349689
- Lot# 350636
Distribution
Distributed nationwide across the United States.
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